- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695809
The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer
Far Eastern Memorial Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Vulvar cancer can be treated with surgery, radiotherapy or chemoradiotherapy. Recurrence of vulvar cancer generally can be detected by imaging study. Currently, there is a paucity of sensitive marker to detect the recurrence of vulvar cancer. G9a is a recently identified protein with histone lysine methyltransferase activity. The role of histone methyltransferases in promoting tumorigenesis and progression of human cancers has been noted in some cancers, such as ovarian cancer, endometrial cancer and cervical cancer. The role of G9a protein in vulvar cancer remains obscure.
All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 will be included. All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data will be recorded from chart review.
The archived specimens will be used for immunohistochemical staining of G9a protein. Tumor size, local invasion, lymph node metastasis, and final disease stage will be determined. Correlation will be performed between G9a and clinical outcome of vulvar cancer.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
New Taipei
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Banqiao, New Taipei, Taiwan, 22050
- Recruiting
- Far Eastern Memorial Hospital
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Contact:
- Sheng-Mou Hsiao, MD
- Phone Number: 1424 +886-2-89667000
- Email: smhsiao2@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 were included.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between clinical outcome of vulvar cancer and G9a
Time Frame: 5 years
|
The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between histopathologic features of vulvar cancer and G9a
Time Frame: 1 year
|
Correlation between histopathologic features (such as tumor grade, lymphovascular space invasion, lymph node metastasis and tumor size) of vulvar cancer and G9a
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a
Time Frame: 1 year
|
Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107008-F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvar Cancer, G9a Protein
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer | Vulvar Squamous Cell Carcinoma | Stage I Vulvar Cancer | Stage II Vulvar CancerUnited States, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedLymphedema | Perioperative/Postoperative Complications | Stage II Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Stage IA Vulvar Cancer AJCC v7 | Stage IB Vulvar Cancer AJCC v7 | Stage IVB...United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage II Vulvar Cancer AJCC v8 | Stage IIIC Vulvar Cancer AJCC v8 | Stage IVA Vulvar Cancer AJCC v8 | Stage III Vulvar Cancer AJCC v8 | Stage IIIA Vulvar Cancer AJCC v8 | Stage IIIB Vulvar Cancer AJCC v8United States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Vulvar Squamous Cell Carcinoma | Stage IVA Vulvar Cancer AJCC v7United States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)UnknownLymphedema | Stage II Uterine Corpus Cancer | Stage IVB Vulvar Cancer | Stage IA Uterine Corpus Cancer | Stage IB Uterine Corpus Cancer | Stage IA Cervical Cancer | Stage IB Cervical Cancer | Stage II Vulvar Cancer | Stage IIA Cervical Cancer | Stage IA Vulvar Cancer | Stage IB Vulvar Cancer | Stage IIIA Vulvar... and other conditionsUnited States
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AGO Research GmbHNot yet recruitingRecurrent Vulvar Cancer | Persistent Vulvar Cancer | Metastatic Vulva Cancer | Locally Advanced Vulvar Cancer
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University of BaselUniversity Hospital Inselspital, Berne; Foundation Cancer Research SwitzerlandUnknownWomen With Vulvar Intraephitelial Neoplasia or Vulvar CancerSwitzerland, Germany
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedLymphedema | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Stage III Vulvar Cancer | Stage IVB Vulvar Cancer | Stage 0 Cervical Cancer | Stage 0 Vulvar Cancer | Stage I Vulvar Cancer | Stage IA Cervical Cancer | Stage IB Cervical... and other conditionsUnited States
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Instituto do Cancer do Estado de São PauloUniversity of Sao Paulo General HospitalActive, not recruiting
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AGO Study GroupPhilipps University Marburg Medical Center; medac GmbHCompletedRadio/Chemotherapy in Node Positive Advanced Vulvar CancerGermany
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